Screening for COVID-19 in Teachers, Childcare Educators, Pupils and Preschoolers

SARS-CoV-2 Clinical Trial

— COKITS  

Official title:

Screening for SARS-CoV-2-Infections in Teachers, Childcare Educators, Pupils and Preschoolers in the State of Mecklenburg-Vorpommern

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04619407
• Other study ID #: BB 179/20
• Status: Completed
• Start date: November 4, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: April 2021
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objectives of this study are 1. to establish the prevalence of SARS-CoV-2 in schools and kindergartens in the State of Mecklenburg-Vorpommern in autumn and winter 2020/2021 2. to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in teachers and childcare educators over time

Description:

Detailed Description: This study aims to collect information on teachers and childcare educators as well as on pupils and preschoolers in the State of Mecklenburg-Vorpommern Over a 5 month period, 5 study visits per participant are planned. At each visit, nasal/throat swabs (for PCR testing) will be collected and participants will be asked to fill in a questionnaire (asking for SARS-CoV-2 risk factors, perceived risk, and impact of the pandemic on their quality of life). In adults, additional blood samples (for SARS-CoV-2 antibody testing) will be collected at the first and the last study visit. This will help to gain a better understanding of viral load and antibody development over time. The remaining blood samples will be stored in a repository for future research. The study is part of a modular SARS-CoV-2-research programme of the University Medicine Greifswald.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 67 Years

Eligibility

Inclusion criteria:

• See cohort descriptions
• Willing to have blood samples stored for future research

Exclusion criteria:

• None

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Diagnostic Test:
• Nasopharyngeal swab
SARS-CoV-2 PCR
• Serum testing
Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)

Locations

Country	Name	City	State
Germany	Greifswald University Medicine	Greifswald

Sponsors (4)

Lead Sponsor	Collaborator
University Medicine Greifswald	Ministry of Education, Science and Culture of the State of Mecklenburg-Vorpommern, Ministry of Social Affairs, Integration and Equality of the State of Mecklenburg-Vorpommern, State Office for Health and Social Affairs of the State of Mecklenburg-Vorpommern

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	5 months
Secondary	Seroprevalence of SARS-CoV-2 antibodies	Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff)	At study inclusion
Secondary	Seroprevalence of SARS-CoV-2 antibodies	Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff)	5 months
Secondary	SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	At study inclusion
Secondary	SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	1 month
Secondary	SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	2 months
Secondary	SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	3 months
Secondary	SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	4 months
Secondary	SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life	As assessed by a monthly questionnaire	5 months
Secondary	Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	At study inclusion
Secondary	Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	1 month
Secondary	Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	2 months
Secondary	Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	3 months
Secondary	Share of participants with SARS-CoV-2 detectable in PCR	Percentage of SARS-CoV-2 PCR positive participants (children and educational staff)	4 months